Product Details for: Keytruda Qlex

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Keytruda Qlex
Rx
002
Injection
Subcutaneous
790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Keytruda Qlex
Rx
Proper Name
pembrolizumab and berahyaluronidase alfa-pmph
BLA Number
761467
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
September 19, 2025
Date of First Licensure
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